Tracking acute treatment and long-term outcomes in children with meningitis
Official title: Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
Run by Hospital Israelita Albert Einstein · NCT07062445 · Data updated 2026-11-12
This registry will collect care and outcome information to see how current treatments affect short- and long-term outcomes in children under 18 with suspected meningitis in Brazil.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | March 29, 2026 |
| Main results expected | December 2026 |
| Study ends | February 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07062445 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 hospitalized at participating Brazilian sites with fever and the specified neurologic or meningeal signs (or age-specific presentations for infants) whose caregivers consent to participation are eligible.
✕Probably not a fit
Patients who decline consent, those treated outside participating hospitals, or children with noninfectious causes of neurologic symptoms are unlikely to benefit directly from the registry's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter clinical registry enrolling children under 18 with suspected acute infectious meningitis at roughly 20 public and private hospitals in Brazil. Clinical and laboratory data are recorded during hospitalization and follow-up visits occur at 28, 90, and 180 days after inclusion. Collected variables include timing and type of antibiotics, corticosteroid initiation, vaccination status, neurological sequelae, and access to rehabilitation services. Primary outcomes are all-cause mortality, hospital length of stay, rehospitalization rate, and incidence of sensorineural hearing loss, with additional etiology-specific and functional outcomes captured as secondary endpoints.
Why it matters
Potential benefit: If successful, the findings could inform national care protocols and reduce mortality and long-term disabilities such as hearing loss among children with meningitis.
How similar studies have gone: Similar multicenter meningitis surveillance and registries have generated useful real-world data internationally, though large prospective pediatric registries in middle-income settings like Brazil are less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fever (axillary temperature ≥37.8°C) followed by two or more of the following symptoms\*: severe headache, vomiting, altered consciousness (confusion, drowsiness, or irritability), photophobia (increased sensitivity to light), presence of seizures OR * Fever accompanied by at least one meningeal irritation sign, such as neck stiffness, Kernig's sign, or Brudzinski's sign OR * Sudden onset of fever and appearance of petechial skin rash or hemorrhagic suffusions * In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle. Exclusion Criteria: * Refusal to provide consent for study participation
Where it's running
-
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Anna M Gomes — Hospital Israelita Albert Einstein
- Study coordinator: Anna M Gomes
- Email: anna.gomes@einstein.br
- Phone: +55 11 2151-1233
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.